b'Gel & Capillary | CE-IVD Assays IGK Gene Clonality AssaysGel and CapillaryAssaysIdentiClone IGK Gene Clonality AssaysAssay Description Performance Characteristics The IdentiClone IGK Gene Clonality Assay is an in vitro diagnosticData from two independent studies that tested more than 300 product intended for PCR-based detection of clonal immunoglobulinpatient sample of varying types suggests the diagnostic accuracykappa light chain gene rearrangements in patients with suspectof selected IdentiClone tests to be 96%. In both peer-reviewed lymphoproliferations. studies, there were no clear false-positive results generated using the IdentiClone tests, and there was a high level of precision. 2 Specifically, the IGK Gene Clonality Assay can be used to: The clinico-histopathological diagnosis correlated well with PCR results in a higher number of patients when compared withIdentify clonality in atypical lymphoproliferative disorders Southern Blot (SB) results, as seen below: Support a differential diagnosis between reactive lesions andPCR/SB concordance: 1hematologic malignanciesAssign presumptive lineage in mature monoclonal IGK: 90% sensitivity / 90% specificity lymphoproliferative disordersIdentify tumor-specific markers (IGK and IGK-K derearrangements) PCR vs. SB analysis relative to histopathology and final diagnosis:for post-treatment monitoringMonitor and evaluate disease recurrence PCR/SB concordance: 2PCR sensitivity: SB sensitivity: IGH + IGK: 85% 98% 39%Summary and Explanation of the Test These test kits include three master mixes. The IGK Tube A masterReferencesmix targets the variable (V) and the joining (J) regions of the immunoglobulin kappa light chain locus, whereas the IGK Tube B1. JJM van Dongen et al., Leukemia 17:2257-2317 (2003).master mix targets kappa deleting element (K de ) rearrangements with2.Y Sandberg et al., J. Mol. Diag. 7(4):495-503 (2005).the V regions and the intragenic J-C regions. The V-K deand J-C intron-K derearrangements are a result of unsuccessful rearrangements retained by the B cell. The third master mix, the Specimen Control Size Ladder, targets multiple genes and generates a series of amplicons of approximately 100, 200, 300, 400, and 600 base pairs to ensure that the quality and quantity of input DNA is adequate to yield a valid result. Figure Legend: Schematic diagram of the immunoglobulin kappa light chain gene complex on chromosome 2p11.2. Shown are the relative positions and orientations for the V-J, and K deprimers, which are included in the IGK master mix tubes.This assay is based on the EuroClonality/BIOMED-2 Concerted Action BMH4-CT98-3936.68'